Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Zanubrutinib 80mg po qd 6 weeks
eltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL.
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Treatment response
The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
Time frame: 6 weeks
Overall response
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication after 6 weeks of treatment
Time frame: 6 weeks
Complete response (CR)
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Time frame: 6 weeks
Time to response
The time from starting treatment to time of achievement of Response
Time frame: 6 weeks
Sustained response
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 12-month follow-up
Time frame: 12 month
Number of patients with bleeding
Number of patients with bleeding complication ( WHO bleeding score)
Time frame: 12 months
Number of patients with adverse events
Number of patients with adverse events
Time frame: 12 months
Duration of response (DOR)
Duration of response at 12-month follow up
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Time frame: 12 months
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Time frame: 12 months